NCT07113340

Carina™ Surgical Platform for Minimal Radical Gastrectomy

Carina™ Platform - A Single-arm Study for Gastrectomy

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: The Affiliated Hospital of Qingdao University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and effectiveness of the laparoscopic surgical system（Carina™ Surgical Platform, developed by Ronovo Surgical, Inc) for use in gastrectomy.

Detailed description

Source data verification: Cross-check between paper and electronic case report forms. Standard Operating Procedures: The investigator is responsible for patient recruitment, while a independent statistician handles data collection and management. When source data is modified, changes must be traceable in both the electronic system and paper documents. Statistical analysis plan: Categorical variables were analyzed using chi-square tests, while ordinal data were assessed using non-parametric tests. Continuous variables were analyzed using independent samples t-tests or non-parametric methods, as appropriate. Handling of Missing Data: Missing data will be handled according to the classification of each dataset. For the Full Analysis Set (FAS), missing values for primary efficacy and safety endpoints will be imputed using the Worst Observation Carry Forward (WOCF) method, and considered as treatment failure or the occurrence of serious complications. No imputation will be performed for missing values in other datasets or for other secondary/exploratory endpoints.

Conditions

• Robotic Gastrectomy
• Stomach Neoplasms

Interventions

Type	Name	Description
DEVICE	Carina™ Surgical Platform, developed by Ronovo Surgical, Inc	A modular surgical robot that offers greater flexibility in the number of instrument arms and surgical layout options.

Timeline

• Start date: 2025-05-01
• Primary completion: 2025-10-01
• Completion: 2025-12-31
• First posted: 2025-08-08
• Last updated: 2025-08-08

Locations

1 site across 1 country: China